Back to results

Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Minimally Invasive Micro Sclerostomy (MIMS)

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female ≥ 18 years
End stage Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye
Optic nerve appearance characteristic of glaucoma in the study eye
Best-corrected visual acuity (BCVA) with ETDRS charts ≤ 6/60
Patient is treated with 0 to 5 hypotensive medications in the study eye
Unsatisfactory IOP (≥ 21 mmHg) at the screening visit in the study eye
If cataract is not present - Shaffer grade ≥ III in all four angle quadrants in the study eye
Subject is able and willing to attend all scheduled follow-up exams
Subject understands and signs the informed consent

Exclusion Criteria:

Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMS procedure or the study eye is pseudophakic with PCIOL.
Congenital or developmental glaucoma in either eye
Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
Subject has history of penetrating keratoplasty (PKP)
Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic.
Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye.
Use of oral hypotensive medication for glaucoma for treatment of the fellow eye
Best-corrected visual acuity worse than 20/50 (Snellen equivalent) in the fellow eye
History of idiopathic or autoimmune uveitis in either eye
Severe trauma in study eye
active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil
Vitreous present in anterior chamber, prior vitrectomy or virteous hemorrhage in study eye
Aphakia
Prior vitreoretinal surgery in study eye
Clinically significant ocular inflammation or infection within 90 days prior to screening
Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions
Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits
Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit
Pregnant or lactating women

Sites / Locations

Dr. Agarwal Eye Hospital Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minimally invasive micro sclerostomy (MIMS)

Arm Description

create a drainage channel at the sclera-corneal junction

Outcomes

Primary Outcome Measures

Serious Adverse Event

Overall incidence of serious adverse events

Drainage Channel Creation

Ability to successfully perform a drainage channel

Secondary Outcome Measures

Serious Adverse Event

Overall incidence of serious adverse events

Intraocular Pressure

Intraocular Pressure between 6 mmHg and 20 mmHg

Full Information

NCT ID

NCT04484155

First Posted

July 20, 2020

Last Updated

November 27, 2022

Sponsor

Sanoculis Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04484155

Brief Title

Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study

Official Title

Minimally Invasive Micro Sclerostomy: First in Man (FIM) Safety and Preliminary Performance Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 16, 2018 (Actual)

Primary Completion Date

March 2, 2020 (Actual)

Study Completion Date

March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanoculis Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Eligible Glaucoma patients will undergo pre-surgery examination including: medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered . The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] . MIMS procedure may be combined with cataract surgery. Patients will be followed up to 24 weeks post operation.

Detailed Description

Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure. Description of MIMS procedure: on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered . creating drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue].MIMS procedure may be combined with cataract surgery. Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least one month. Patients will be followed up to 24 weeks post operation. The following measurements will be included: Intra Ocular Pressure (IOP) Best Corrected Visual Acuity (BCVA) Slit Lamp Biomicroscopic evaluation Anterior Segment Optical coherence tomography (OCT) Fundus Examination

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minimally invasive micro sclerostomy (MIMS)

Arm Type

Experimental

Arm Description

create a drainage channel at the sclera-corneal junction

Intervention Type

Device

Intervention Name(s)

Minimally Invasive Micro Sclerostomy (MIMS)

Intervention Description

The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.

Primary Outcome Measure Information:

Title

Serious Adverse Event

Description

Overall incidence of serious adverse events

Time Frame

12 weeks

Title

Drainage Channel Creation

Description

Ability to successfully perform a drainage channel

Time Frame

Index procedure day

Secondary Outcome Measure Information:

Title

Serious Adverse Event

Description

Overall incidence of serious adverse events

Time Frame

24 Weeks

Title

Intraocular Pressure

Description

Intraocular Pressure between 6 mmHg and 20 mmHg

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥ 18 years End stage Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye Optic nerve appearance characteristic of glaucoma in the study eye Best-corrected visual acuity (BCVA) with ETDRS charts ≤ 6/60 Patient is treated with 0 to 5 hypotensive medications in the study eye Unsatisfactory IOP (≥ 21 mmHg) at the screening visit in the study eye If cataract is not present - Shaffer grade ≥ III in all four angle quadrants in the study eye Subject is able and willing to attend all scheduled follow-up exams Subject understands and signs the informed consent Exclusion Criteria: Ocular conditions with a poorer prognosis in the fellow eye than in the study eye Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMS procedure or the study eye is pseudophakic with PCIOL. Congenital or developmental glaucoma in either eye Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye Subject has history of penetrating keratoplasty (PKP) Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic. Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye. Use of oral hypotensive medication for glaucoma for treatment of the fellow eye Best-corrected visual acuity worse than 20/50 (Snellen equivalent) in the fellow eye History of idiopathic or autoimmune uveitis in either eye Severe trauma in study eye active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil Vitreous present in anterior chamber, prior vitrectomy or virteous hemorrhage in study eye Aphakia Prior vitreoretinal surgery in study eye Clinically significant ocular inflammation or infection within 90 days prior to screening Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit Pregnant or lactating women

Facility Information:

Facility Name

Dr. Agarwal Eye Hospital Ltd.

City

Chennai

ZIP/Postal Code

600086

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34731867

Citation

Geffen N, Kumar DA, Barayev E, Gershoni A, Rotenberg M, Zahavi A, Glovinsky Y, Agarwal A. Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure. J Glaucoma. 2022 Mar 1;31(3):191-200. doi: 10.1097/IJG.0000000000001955.

Results Reference

derived

Learn more about this trial

Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study

We'll reach out to this number within 24 hrs